Regulatory Affairs Specialist

Join our team as a Senior Regulatory Affairs Specialist and play a key role in ensuring the implementation, execution, and management of local regulatory activities in Italy. As a member of our Regulatory Affairs team, you will be responsible for supporting the planning, coordination, and management of regulatory activities, including regulatory submissions to national regulatory authorities, labeling activities, and maintenance of the regulatory quality management system.

• Support the Regulatory Affairs team in the planning, coordination, and management of regulatory activities, including regulatory submissions to national regulatory authorities.
• Manage labeling activities, including SmPC, package leaflet, and labeling, as per local requirements and internal processes.
• Maintain the regulatory quality management system, follow-up with Corrective Action Preventative Actions (CAPAs), and changes.
• Draft and update SOPs under regulatory responsibility.
• Provide support in the training on SmPC/Educational Materials, if required.
• Maintain compliance of the managed activities and assure proper archiving of all relevant documents related to those activities.
• Prepare and submit variations, update national databases, and support the regulatory team during audit and inspection.
• Monitor regulatory/pharmaceutical regulations (Regulatory intelligence) for the relevant therapeutic areas and share information internally.

• Experience in the pharma industry in regulatory affairs, including experience in a similar position.
• Good knowledge of applicable local and global pharmaceutical regulations and related ethical code of practice required for GXP compliance.
• Ability to pragmatically interpret GxP and Code of Practice regulations, laws, and guidelines with ability to share CMC experience.
• Experience with MRP and DCP and global projects innovation and life cycle.
• Strong written and verbal communication and organizational skills.
• Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization.
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs.
• Ability to multi-task and prioritize work.
• Fluency in English (speaking, reading, and writing).
• Knowledge in QMS activities and Electronic Quality Systems.
• Proficiency in Microsoft applications (Excel, Word, PowerPoint).

Bachelor's degree or equivalent, preferably in life sciences (pharmacy, biology, etc.). Master in Regulatory Affairs will be a plus.